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Table 3 Frequency of NPAEs in P. vivax malaria patients given tafenoquine/chloroquine, primaquine/chloroquine or placebo/chloroquine [9]

From: Neurological and psychiatric safety of tafenoquine in Plasmodium vivax relapse prevention: a review

Adverse event, n (%)

TQ + CQ

PQ + CQ (N = 50)

Placebo + CQ (N = 54)

50 mg (N = 55)

100 mg (N = 57)

300 mg (N = 57)

600 mg (N = 56)

Any nervous system disorder

17 (31)

17 (30)

13 (23)

16 (29)

17 (34)

21 (39)

 Headache

14 (25)

17 (30)

10 (18)

16 (29)

14 (28)

20 (37)

 Dizziness

7 (13)

2 (4)

5 (9)

4 (7)

5 (10)

5 (9)

 Migraine

0

0

0

0

0

1 (2)

 Tremor

0

0

1 (2)

1 (2)

0

0

 Paraesthesia

0

0

0

1 (2)

0

0

 Sciatica

0

1 (2)

0

0

0

0

 Burning sensation

1 (2)

0

0

0

0

0

 Syncope

0

0

0

0

1 (2)

0

 Dysaesthesia

0

0

0

0

1 (2)

0

Any psychiatric disorder

2 (4)

3 (5)

5 (9)

3 (5)

1 (2)

1 (2)

 Insomnia

2 (4)

3 (5)

5 (9)

3 (5)

3 (6)

1 (2)

 Tic

0

0

0

1 (2)

0

0

Expanded termsa

 Asthenia

5 (9)

4 (7)

1 (2)

5 (9)

0

0

 Fatigue

0

1 (2)

1 (2)

0

0

0

  1. CQ chloroquine, PQ primaquine, TQ tafenoquine
  2. aExpanded terms: labyrinthitis, vertigo, vestibular disorder, asthenia, fatigue, and alcohol intolerance were also considered with possible reference to vestibulocochlear function